TY - JOUR
T1 - Generalizability of the Results of Efficacy Trials in First-Episode Schizophrenia
T2 - Comparing Outcome and Study Discontinuation of Groups of Participants in the Optimization of Treatment and Management of Schizophrenia in Europe (OPTiMiSE) Trial
AU - Nasib, Lyliana G
AU - Winter-van Rossum, Inge
AU - Zuithoff, Nicolaas P A
AU - Boudewijns, Zimbo S R M
AU - Leucht, Stefan
AU - Kahn, René S
N1 - Funding Information:
and Boudewijns report no financial or other relationship relevant to the subject of this article. Funding/support: The Optimization of Treatment and Management of Schizophrenia in Europe (OPTiMiSE) study was funded by the European Commission Seventh Framework Program (HEALTH-F2-2010-242114). Role of the sponsor: The European Commission Seventh Framework Program had no role in the study design, data collection, data analyses and interpretation, writing of this report, or decision to submit the report for publication. Acknowledgments: We kindly thank all patients that participated in this trial. Supplementary material: Available at Psychiatrist. com.
Publisher Copyright:
© 2023 Physicians Postgraduate Press, Inc.
PY - 2023/3/29
Y1 - 2023/3/29
N2 - Objective: In the majority of randomized controlled trials (RCTs) conducted in schizophrenia populations, patients suffering from a substance use disorder (SUD) or suicidality are excluded. Excluding these patients from RCTs might impact the generalizability of results. The aim of this study is to determine whether excluding patients with suicidality and/or SUD impacts RCT results on symptomatic remission, premature study discontinuation, symptom severity, and social functioning. Methods: Across Europe and Israel, 481 patients with first-episode schizophrenia, schizophreniform disorder, or schizoaffective disorder, based on DSM-IV criteria, were recruited between May 26, 2011, and May 15, 2016, for the Optimization of Treatment and Management of Schizophrenia in Europe (OPTiMiSE) trial. Baseline characteristics and follow-up assessments were compared between patients with versus without baseline SUD and/or suicidality. Results: A total of 446 patients met eligibility criteria for the OPTiMiSE trial and initiated amisulpride treatment, of whom 404 (91%) had data available on suicidality, SUD, duration of illness, and CDS score. Of the 360 eligible patients with baseline data on suicidality and SUD, 106 patients had comorbid suicidality and/or SUD while 254 patients had neither of these comorbidities. No significant differences in the likelihood to achieve symptomatic remission or to prematurely discontinue the study were found when comparing comorbid versus non-comorbid patients (P= .27). There were no significant differences in symptom severity and social functioning between the groups. Comorbid patients had a higher level of depressive symptoms and more impaired social functioning compared to non-comorbid patients. Discussion: Excluding first-episode schizophrenia patients with comorbidities from clinical trials unlikely affects key outcome measures. It is recommended to include patients with comorbidities in clinical trials while carefully monitoring suicidality and implementing safety plans to gain insight into efficacy and safety of treatment in this substantial patient population.
AB - Objective: In the majority of randomized controlled trials (RCTs) conducted in schizophrenia populations, patients suffering from a substance use disorder (SUD) or suicidality are excluded. Excluding these patients from RCTs might impact the generalizability of results. The aim of this study is to determine whether excluding patients with suicidality and/or SUD impacts RCT results on symptomatic remission, premature study discontinuation, symptom severity, and social functioning. Methods: Across Europe and Israel, 481 patients with first-episode schizophrenia, schizophreniform disorder, or schizoaffective disorder, based on DSM-IV criteria, were recruited between May 26, 2011, and May 15, 2016, for the Optimization of Treatment and Management of Schizophrenia in Europe (OPTiMiSE) trial. Baseline characteristics and follow-up assessments were compared between patients with versus without baseline SUD and/or suicidality. Results: A total of 446 patients met eligibility criteria for the OPTiMiSE trial and initiated amisulpride treatment, of whom 404 (91%) had data available on suicidality, SUD, duration of illness, and CDS score. Of the 360 eligible patients with baseline data on suicidality and SUD, 106 patients had comorbid suicidality and/or SUD while 254 patients had neither of these comorbidities. No significant differences in the likelihood to achieve symptomatic remission or to prematurely discontinue the study were found when comparing comorbid versus non-comorbid patients (P= .27). There were no significant differences in symptom severity and social functioning between the groups. Comorbid patients had a higher level of depressive symptoms and more impaired social functioning compared to non-comorbid patients. Discussion: Excluding first-episode schizophrenia patients with comorbidities from clinical trials unlikely affects key outcome measures. It is recommended to include patients with comorbidities in clinical trials while carefully monitoring suicidality and implementing safety plans to gain insight into efficacy and safety of treatment in this substantial patient population.
KW - Amisulpride/therapeutic use
KW - Antipsychotic Agents/adverse effects
KW - Europe/epidemiology
KW - Humans
KW - Psychotic Disorders/diagnosis
KW - Schizophrenia/drug therapy
KW - Substance-Related Disorders/epidemiology
KW - Treatment Outcome
UR - http://www.scopus.com/inward/record.url?scp=85151313203&partnerID=8YFLogxK
U2 - 10.4088/JCP.22m14531
DO - 10.4088/JCP.22m14531
M3 - Article
C2 - 36988483
VL - 84
JO - The Journal of clinical psychiatry
JF - The Journal of clinical psychiatry
IS - 3
M1 - 46380
ER -